Replies to post #145153 on Bioelectronics Corp (BIEL)

[DewmBoom]

The key benefit for Biel is here. Essentially, expediting the FDA approval for RecoveryRX, after submitting the 510K

In most cases, applicants will eventually submit one or more formal applications to FDA, such as an Investigational Device Exemption (IDE), De Novo, 510(k), or Premarket Approval (PMA). The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstration of reasonable assurance of safety and effectiveness still applies.